# K182472: Cepheid Xpert GBS LB Control Panel

- Pathway: 510(k) (Traditional)
- Applicant: Microbiologics, Inc.
- Decided: Nov 8, 2018 after 59 days
- Product code: PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays)
- Device class: 2
- Regulation: 21 CFR 866.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150058 (2016). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150058: Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak, Bio-Rad Laboratories (2016) Summary page 4.

## Most influential descendants
- K190086: Cepheid Xpert Respiratory Control Panel (2019), 0 descendants of its own
- K191168: Cepheid Xpert SA Nasal Complete Control Panel (2019), 0 descendants of its own
- K191172: Cepheid Xpert MRSA NxG Control Panel (2019), 0 descendants of its own
- K190223: Cepheid Xpert CT/NG Control Panel (2019), 0 descendants of its own

## Indications for use
The Cepheid Xpert® GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert® GBS LB Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert® GBS LB Control Panel is not intended to replace manufacturer controls provided with the device.

Source page: https://510kreport.com/device/K182472
Methodology: https://510kreport.com/methodology